Global Quality Systems & Compliance Lead

Straumann Group; Basel; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Straumann Group in Basel is seeking a Team Leader Quality Systems & Compliance (m/f/d) to steer Document Control & Training across the Group and to act as Global Business Process Owner for these processes. You will ensure regulatory compliance, maintain harmonized QMS processes, and drive continuous improvement, including audits and KPI reporting, in an international matrix setup.

Fluent English is required; a university degree and 5+ years in quality/regulatory roles within medical devices or

Qualifikationen

• University degree or equivalent in quality, medicine, or related scientific field.
• Minimum 5 years in Quality Management or Regulatory Affairs in medical devices or pharma.
• Experience leading a team and cross-functional collaboration.

Aufgaben

• Lead Document Control & Training across Straumann Group, ensuring compliant document lifecycle and change control.
• Own eQMS governance and ensure regulatory alignment for current and future portfolio.
• Drive global KPIs for Document Control & Training and support audits by authorities.
• Promote harmonized processes and support rollout to new entities across the Group.
• Lead or contribute to continuous improvement and digitalization projects in QMS.

Kenntnisse

Team leadership

Quality management

Regulatory affairs

ISO 13485

MDR 2017/745

FDA QMSR (21 CFR Part 820)

Document management

Project management

Digitalization (Power BI, Power Autom​

English proficiency

Ausbildung

University degree in quality, medicine, pharmacy, engineering, IT or related field

Tools

Power BI

Power Automate

Generative AI tools

Jobbeschreibung

Straumann Group in Basel is seeking a Team Leader Quality Systems & Compliance (m/f/d) to steer Document Control & Training across the Group and to act as Global Business Process Owner for these processes. You will ensure regulatory compliance, maintain harmonized QMS processes, and drive continuous improvement, including audits and KPI reporting, in an international matrix setup.

Fluent English is required; a university degree and 5+ years in quality/regulatory roles within medical devices or